In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and...more
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more
The outbreak of the COVID-19 pandemic in 2020 spurred rapid medical and technological innovation, leading to new medicines and devices designed in response to the virus. Under the traditional U.S. Food and Drug Administration...more
ASTM International recently approved a new performance standard that will tell consumers just how much protection their cloth face masks offer. Some face coverings like N-95 respirators and surgical masks must meet certain...more
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others...more
5/12/2021
/ ACIP ,
Biden Administration ,
Centers for Disease Control and Prevention (CDC) ,
Contamination ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
Moderna Inc. ,
Pfizer ,
Vaccinations
On Friday, March 26, 2021, over 180 attendees worldwide attended McKinsey & Company’s first Global HealthTech CEO Connect of 2021. The discussion focused on regulatory and legal considerations for software as a medical device...more
4/12/2021
/ Coronavirus/COVID-19 ,
Data Transfers ,
EU ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
International Medical Device Regulators Forum (IMDRF) ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Medical Directives ,
Popular ,
Software
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more
3/31/2021
/ Biden Administration ,
CARES Act ,
Collaboration ,
Coronavirus/COVID-19 ,
Defense Contracts ,
Defense Production Act ,
Department of Justice (DOJ) ,
EU ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
Life Sciences ,
Merck ,
Pharmaceutical Industry ,
Popular ,
Private Sector ,
Public Health Emergency ,
Supply Chain ,
Trump Administration ,
Vaccinations ,
World Health Organization
Sunday, February 28, 2021, was Rare Disease Day. With so much focus on COVID-19 throughout 2020, it’s important to recognize the continued work done in rare disease drug development by sponsors and FDA throughout 2020. In...more
While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly,...more
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year....more
Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of...more
On December 2, 2020, the U.K. became the first Western nation to approve the use of Pfizer/BioNTech’s COVID-19 (SARS-CoV-2) vaccine for mass inoculation. As pressure mounts on U.S. regulators to follow suit, the next 30 days...more
12/7/2020
/ ACIP ,
Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Infectious Diseases ,
Moderna Inc. ,
Pfizer ,
Pharmaceutical Industry ,
UK ,
Vaccinations
On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely...more
Welcome to the inaugural edition of Morrison & Foerster’s quarterly newsletter on recent developments in arbitrations, investigations, and commercial and intellectual property litigation that may affect Japanese...more
11/6/2020
/ Arbitration ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Electronic Communications ,
FCPA Corporate Enforcement Policy (CEP) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
International Chamber of Commerce (ICC) ,
Japan ,
LCIA ,
Remote Hearings ,
SCC ,
Securities and Exchange Commission (SEC)
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and...more
FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products,...more
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an...more
FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s...more
A federal court in Florida has entered a temporary restraining order against the Genesis II Church of Health and Healing (Genesis) and four principals associated with the entity. The order requires defendants to immediately...more
As the coronavirus (COVID-19) outbreak continues to impact business, markets, and society at large, our attorneys who work with private equity (PE) clients in the U.S. have been having conversations with those clients about...more
As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical...more
A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included: Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell,...more
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents...more
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more
3/19/2020
/ Coronavirus/COVID-19 ,
Deceptively Misdescriptive ,
Enforcement Actions ,
False Advertising ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud ,
FTC Act ,
Unfair or Deceptive Trade Practices ,
Warning Letters